Advancing HIV/AIDS Research within the Mission of the NIDCD (R01 Clinical Trial Optional)

The NIH's "Advancing HIV/AIDS Research within the Mission of the NIDCD" program invites applications for R01 research project grants that focus on the intersection of HIV/AIDS and communication disorders. This initiative is administered by the National Institute on Deafness and Other Communication Disorders (NIDCD) and aims to expand understanding of how HIV impacts communication processes, including hearing, balance, taste, smell, voice, speech, and language. Research supported by this NOFO must align with the NIH Office of AIDS Research (OAR) priorities, addressing the etiology, pathology, detection, treatment, and prevention of disorders related to communication and their intersections with HIV. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, and foreign institutions. Application budgets are capped at $499,999 in direct costs annually, with a maximum project duration of five years. All submissions must follow NIH's registration requirements, including registering with SAM.gov and eRA Commons. Proposals must focus on hypothesis-driven basic, translational, or clinical research, with an emphasis on collaborative approaches leveraging existing HIV/AIDS cohorts or infrastructure. Key research objectives include studying the impact of acute and chronic HIV infection on hearing and communication, exploring adverse effects of HIV treatments on balance and sensory functions, and developing strategies to prevent or treat communication disorders in people living with HIV (PLWH). Applications may include clinical trials but are restricted to low-risk trials that do not require FDA oversight. Examples of eligible studies include investigations into the neurophysiological mechanisms underlying HIV-related communication disorders and interventions to improve outcomes. Applications are reviewed for their significance, innovation, rigor, and alignment with NIH priorities. Review criteria also consider investigator qualifications, institutional resources, and adherence to data-sharing policies. Submissions must include a Data Management and Sharing Plan, and additional materials like a research strategy and justification of proposed controls. Incomplete or noncompliant applications will not be reviewed. Deadlines include submission windows on May 7, 2025; September 7, 2025; and January 7, 2026, with additional cycles through January 2028. Applicants are encouraged to submit early to address any technical errors. A Letter of Intent, though not required, is due 30 days before the application date. Funding decisions will be based on peer review outcomes, relevance to program goals, and available resources. This NOFO offers a critical opportunity to bridge HIV/AIDS research with NIDCD’s mission, fostering innovation in understanding and mitigating the unique challenges faced by PLWH. For further guidance, applicants can access resources through NIH's application platforms and consult NIDCD contacts.